Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective randomized, double-blind study to compare the clinical efficacy of infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy with corticosteroids and placebo. We hypothesize that a two-month treatment period with propranolol plus corticosteroids is more effective at reducing infantile hemangioma size and vascularity when compared to corticosteroids used without propranolol for the same time period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Children's Hospital
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Propranolol

Criteria

Inclusion Criteria:

• Age 0 to < 9months

• Patients with clinical, radiographic or histologic diagnosis of infantile hemangioma (IH) requiring medical treatment

• IH patients whose parents desire medical treatment for the IH

• Stable cardiac function

Exclusion Criteria:

• IH patients over 9 months of age.

• Hypersensitivity to propranolol

• Untreated heart failure: If the patient has heart failure associated with the hemangioma, propranolol would be initiated after anti-congestive therapy and under observation as an in-patient.

• Atrioventricular (AV) block

• Resting heart < 2 SD of normal*(below)

• Resting blood pressure < 2 SD of normal**(below)

• Wolff-Parkinson-White syndrome (WPW)

• History of unexplained syncope

• Bronchial asthma

• History of impaired renal or liver function

• Diabetes mellitus